<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190413043257N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-23</date_registration>
      <primary_sponsor>Faculty of Medical Sciences, Tarbiat Modares University</primary_sponsor>
      <public_title>education for promotion weight management among children based on PRECEDE PROCEED</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluation of an educational program to promotion of weight management among 3-5 years children  in Tehran based on PRECEDE PROCEED model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38800</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the random numbers table, the participants will be assigned in the control and intervention groups. This table contains a lot of numbers without a specific pattern. Initially, the researcher predetermined the direction of reading numbers (for example, left, right, up, or down). the second is to consider numbers for different groups, for example, even numbers for the intervention group and the odd numbers for the control group. Then the researcher points to one of the numbers and moves in one of the predicted directions and records the numbers and assigns them to different groups, Blinding description: Participants won't be informed that they are in the intervention group or in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>promotion of weight management.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Tehranian preschoolers' mothers in the intervention group will be received a designed educational program to manage the weight of children. This educational program will be based on the results from the qualitative phase of the study and PRECEDE / PROCEED model. This model is one of the most comprehensive and widely used of models in health education to assess social, epidemiological, behavioral and educational factors regarding behavioral modification. Training includes educational sessions in the form of questions and answers about the history of weight disorders in preschoolers and its complications in childhood and adolescence; as well as priority behaviors such as nutrition, physical activity. Appropriate training materials will be used to train them. Intervention 2: Control group: Tehranian preschoolers' mothers in the control group will be received a usual program of preschool.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic characteristics are confidential, but information on the consequences of weight, quality of life, and behavior changes are shared.

When:
A week after receiving a request by email, write to the main investigator.

To whom:
The researchers in scientific institutions and university of non-communicable disease prevention unit in the Ministry of Health.

Conditions:
Health departments of medical sciences universities

Where to obtain:
Contact Dr. Fazlollah Ghobranpour by email address GHOFRANF@modares.ac.ir

How to obtain:
A week after receiving a request by email to the main investigator.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fazlollah Ghofranipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modarres University, Nasr, Jehran-Jalal Al Ahmad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3869</telephone>
        <email>ghofranf@modares.ac.ir</email>
        <affiliation>Faculty of Medical Sciences, Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fazlollah Ghofranipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modarres University,  Nasr, Jalal Al Ahmad,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3869</telephone>
        <email>ghofranf@modares.ac.ir</email>
        <affiliation>Faculty of Medical Sciences, Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>preschools' mothers residing Tehran</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>illness child and taking drugs
unwilling to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90-F98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Behavioural and emotional disorders with onset usually occurring in childhood and adolescence.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Tehranian preschoolers' mothers in the intervention group will be received a designed educational program to manage the weight of children. This educational program will be based on the results from the qualitative phase of the study and PRECEDE / PROCEED model. This model is one of the most comprehensive and widely used of models in health education to assess social, epidemiological, behavioral and educational factors regarding behavioral modification. Training includes educational sessions in the form of questions and answers about the history of weight disorders in preschoolers and its complications in childhood and adolescence; as well as priority behaviors such as nutrition, physical activity. Appropriate training materials will be used to train them.</i_keyword>
      <i_keyword>Control group: Tehranian preschoolers' mothers in the control group will be received a usual program of preschool.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight changes. Timepoint: before intervention, Immediately and three months after intervention. Method of measurement: Measuring the weight of children by digital scales.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life scores. Timepoint: Measurement of quality of life before intervention as well as immediately and 3 months after intervention. Method of measurement: Using children's Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Score of nutritional behaviors of children. Timepoint: Measurement of nutritional behaviors of children before intervention as well as immediately and 3 months after intervention. Method of measurement: Using nutritional behaviors questionnaire of children.</sec_outcome>
      <sec_outcome>Score of physical activity behavior of children. Timepoint: Measurement of physical activity behaviors of children before intervention as well as immediately and 3 months after intervention. Method of measurement: Using physical activity behavior questionnaire of children.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Faculty of Medical Sciences, Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-27</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Nasr, Jalal al ahmad street, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
